ThermaCor 1200 Infusion System

GUDID 00857893006226

Australia Detachable Power Cord Set

SMISSON-CARTLEDGE BIOMEDICAL, LLC

Conduction blood/fluid warmer
Primary Device ID00857893006226
NIH Device Record Keyaae038ff-8c47-4df8-bf48-8c3402950651
Commercial Distribution StatusIn Commercial Distribution
Brand NameThermaCor 1200 Infusion System
Version Model NumberRCAU-1200
Company DUNS087687179
Company NameSMISSON-CARTLEDGE BIOMEDICAL, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(478)330-6205
Emaildonna@t3med.com
Phone+1(478)330-6205
Emaildonna@t3med.com
Phone+1(478)330-6205
Emaildonna@t3med.com
Phone+1(478)330-6205
Emaildonna@t3med.com
Phone+1(478)330-6205
Emaildonna@t3med.com
Phone+1(478)330-6205
Emaildonna@t3med.com
Phone+1(478)330-6205
Emaildonna@t3med.com
Phone+1(478)330-6205
Emaildonna@t3med.com
Phone+1(478)330-6205
Emaildonna@t3med.com
Phone+1(478)330-6205
Emaildonna@t3med.com
Phone+1(478)330-6205
Emaildonna@t3med.com
Phone+1(478)330-6205
Emaildonna@t3med.com
Phone+1(478)330-6205
Emaildonna@t3med.com
Phone+1(478)330-6205
Emaildonna@t3med.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100857893006226 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FRNPump, infusion

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-12-03
Device Publish Date2019-11-25

On-Brand Devices [ThermaCor 1200 Infusion System]

00857893006219European Detachable Power Cord Set
008578930061963 Spike Set Holder
00857893006189UK Detachable Power Cord Set
10857893006155Drape
00857893006141Rigid Fluid Reservoir Holder
00857893006134Rigid Fluid Reservoir
20857893006121Extension Line
108578930061173 Spike Set
20857893006107Patient Line
20857893006091Dual Line
00857893006080Cassette
10857893006070Cassette with Dual Line
10857893006063Cassette with Patient Line
10857893006056Cassette with Patient Line and 3 Spike Set
00857893006042Replacement Power Cord
00857893006035Replacement Silpad
00857893006028Replacement Footswitch
00857893006011Replacement Component Guard
00857893006004ThermaCor 1200 Rapid Infuser
00857893006226Australia Detachable Power Cord Set

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.